Can Pragmatic Research, Real-world Data and Digital Technologies Aid the Development of Psychedelic Medicine?
A paper was recently published, urging for supplementation of traditional confirmatory trials with so-called "pragmatic clinical trials (PCTs)".
PCTs are designed to inform decision-makers regarding the comparative balance of benefits vs risks of a biomedical or behavioral health intervention at the individual or population level.
Usually, these occur after a treatment has been approved by the FDA in clinical practice. However, these confirmatory trials may not optimally advance our understanding of safety and best practice for psychedelics. Therefore, this paper presents a framework for pre-approval PCTs of psychedelics which relies on digital health technology to learn more about real-world best practices.
This new system could be a good idea because:
- Unlike most treatments under FDA evaluation, psychedelics are already in use
- Psychedelics have been shown to have a favorable safety/toxicity profile
- There is a building momentum for broadening of legal jurisdictions and increased decriminalization
- Digital biomarkers and remote monitoring tools can generate meaningful data and ideas for best practice if used appropriately
Abstract
Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.
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